Catheters may be inserted into a patient's vasculature and deployed at various locations within the patient for a wide variety of purposes and medical procedures. For example, one type of catheter is used in percutaneous catheter intervention (PCI) for the treatment of a vascular constriction generally known as a stenosis. In this instance, the catheter has a distally mounted balloon that can be placed, in a deflated or unexpanded condition, within the stenosis, and then inflated or expanded to dilate the narrowed lumen of a blood vessel. This type of balloon dilation therapy is generally referred to as percutaneous transluminal angioplasty (PTA). When the treatment is more specifically intended for vessels of the heart, the process is known as percutaneous transluminal coronary angioplasty (PTCA). In other PCI procedures, a stent is expanded into contact with the vessel wall to prevent narrowing or restenosis of the artery.
For example, FIGS. 1 and 2 illustrate the deployment of a PTCA treatment catheter 16 within a patient's vasculature. To treat small diameter vessels remote from an entry point into a patient, a guiding catheter 10 may be used to span the distance. Guiding catheter 10 is typically inserted into a large artery 12 near the patient's groin and is then advanced towards the heart H to the entry opening or ostium of a diseased coronary artery. Guiding catheter 10 provides a conduit through which catheters and guidewires, such as treatment catheter 16 and a guidewire 18, can be passed from outside the patient to the vessel being treated. Treatment catheter 16 generally includes a flexible elongated tubular shaft and a luer fitting 14. For certain interventional procedures, treatment catheter 16 may include a dilatation balloon and/or a stent disposed along a distal portion thereof.
Referring now to FIGS. 3-4, catheters are commonly packaged and stored in a packaging hoop 11 as shown in FIG. 3 in accordance with the teachings of the prior art. Packaging hoop 11 consists of a coiled tube 13 having a proximal opening 17 through which treatment catheter 16 is inserted. Several clips 15 are coupled to tube 13 to maintain the tube in the coiled configuration. The overall diameter of packaging hoop 11 is selected to be as small as possible without imparting a lasting curve shape to the generally straight medical device during the shelf life thereof. An overly small diameter hoop 11 may also create excessive friction forces and thereby possibly cause product damage during loading or unloading of the medical device. Luer fitting 14, located at the proximal end of treatment catheter 16, has an area 19 that fits into proximal opening 17 of tube 13, as shown in FIG. 4, in order to secure treatment catheter 16 in packaging hoop 11 until it is removed for clinical use. One potential issue with utilizing clips 15 for holding tube 13 in the coiled configuration is that the packaging may not stay flat because clips 15 cannot grip tube 13 with much force without undesirably pinching or kinking the tubing and thereby restricting the loading and unloading of treatment catheter 16. Furthermore, tube 13 may separate from clips 15 during distribution.
In addition to coiled tube 13 and clips 15, catheter packaging typically requires additional parts or components such as a sealed pouch that completely envelopes the entire hoop 11. In addition, a sealed pouch further requires that the pouch be fully contained within a box or carton in order to protect the pouch. One potential issue with this packaging configuration is that the pouch can move inside the box during transport. This creates the possibility for the tube 13 or clips 15 to pierce the pouch and compromise the sterility of the catheter. If this were to occur, a breach of the pouch may be undetectable by the operator.
Accordingly, there remains a need in the art for improved packaging that overcomes these disadvantages of currently available catheter packaging, as well as a need to reduce the number of packaging components and the cost of packaging.